Canada markets close in 4 hours 35 minutes

Mesoblast Limited (MEOBF)

Other OTC - Other OTC Delayed Price. Currency in USD
Add to watchlist
0.55170.0000 (0.00%)
As of 09:30AM EDT. Market open.

Yahoo Finance will soon be upgrading our Conversations message board platform to provide a better experience for our users. Only comments published since April 21, 2021 will be visible on Yahoo Finance after the upgrade. If you wish to download and save any of your older comments, please submit a request via the Privacy Dashboard by no later than Sept. 30.

Sign in to post a message.
  • M
    MarketMania
    @LongStock - it's been a long time my friend - dating back to the Osiris days (10+ years). Our day will be here soon. Long time - no talk - hope all is well.
  • M
    Mere M
    Well done to the MESO team, they DID exactly as they said they would...remembering one of the highest [ex] members of the FDA, now sits on the MESO Board....you can join the dots!
  • L
    LongStock
    Okay, can we stop riding Mesoblast about the SRaGvHD re-submission...it's submitted.

    https://investorsmedia.mesoblast.com/static-files/4ea53823-b66a-466b-83a2-a91a0f8f8ea3
  • P
    Prasanna
    Now the Meso team is free to focus on CHF.. I think CHF too will need in-depth documentation for its approval. Hope we get these two out quickly within this year..
  • B
    Bruce
    Filed....
  • M
    MAGA
    Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD
    Mesoblast Limited
    Sun, October 2, 2022 at 6:52 PM
    In this article:

    Mesoblast Limited

    NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

    Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Company’s complete response to the FDA. Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

    Survival outcomes have not improved over the past two decades for children or adults with the most severe forms of SR-aGVHD.1-3 The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.

    “The submission summarizes controlled data providing further evidence of remestemcel-L’s ability to save lives,” said Dr. Silviu Itescu, Chief Executive of Mesoblast. “Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.”
  • M
    MarketMania
    @GroupInvester - timing is everything. .You want to be right and you've been right - up to this point. But, IMO, you'll be wrong - very wrong. This is a buying opportunity - but you continue to pile on and state the obvious. I mentioned $APLS and you said, it was apples and oranges. I disagreed and think there's a lot of similarities. Look @ APLS and how it's trading in this environment - can you name another stock performing better. I think we'll soon say the same about MESO.. Patience is the name of the game.

    BTW - thanks Left-e, Turtle, etc for their commentary over the last 1+ years.

    GLTA!
  • d
    didja
    i hope they pay the 3 month review fee.
  • W
    Will
    Interesting that they refer to it as “new information submitted” rather than a new submission?

    Any chance of a quick turnaround?
  • t
    tim
    Today is a good day 😀 very happy that Mesoblast have resubmitted as per their intention and effectively on time. Over the years I have struggled with the communications from the company, so it’s great to have this done effectively on time.

    Couldn’t help myself … had to top up 👍

    Let the countdown begin.
  • F
    Frank B
    Yes they filed
  • L
    Left-e
    I would simply point out that the quarter isn't over yet... at least not for reporting purposes. If SI had been led to believe the FDA might accept or reject the vaunted “re-submission” by the end of the calendar third quarter, that would have been CoB in Silver Spring, Maryland on Friday, September 30. In other words, Saturday in Melbourne. And since tomorrow - make that today - Monday, October 3 is Labour Day with a “u” in Victoria.... it means the time for Mesoblast reporting of significant Q3 events extends out to the first Tuesday or even Wednesday in October. That's of course if there indeed was a significant event in the calendar third quarter... and I have little doubt that THAT hinges on FDA action and not just Mesoblast action. No way SI is going to issue a PR saying, “yep, we submitted all the papers and data, and now we're just waiting on the FDA to decide whether we checked all the checkboxes correctly and whether they might deign to review our humble re-submission, let me get back to you on that part”. Not going to happen imo. Which means the “re-submission” everyone is talking about probably already happened in a rolling fashion at least a month or two ago and the ball is now in the FDA court. The FDA has been known to surprise and they've been known to run late on so-called deadlines especially when it involves a first-in-class med. And SI is certainly not going to put out a PR saying, “Uh, uh, sorry folks, we're waiting on the FDA who told me they'd have this done by now, but let me adjust my expectation to... uh, maybe next week if not next month”. SI talks when he has something significant and definitive to say, and that's going to be when the FDA tells him he has something to say. So, I wouldn't get too bunched up over this... enjoy the market uncertainty and have some investing fun.... realizing of course it could go EITHER way.
  • d
    didja
    hopefully this is enough to remind investors that the potential of reml was never in doubt. batch consistency is an easier hurdle. nvax went through the same complete response for their vaxx and it was a technical manufacturing process. the clinical followup is just to show the same results with the new and improved process which was clearly done if the compassionate use data is allowed. the advisory board meets in 4-5 months normally with the chf meeting in the meantime. 2.5 years of patience.
  • L
    Left-e
    The PR is not generating an alert in "Today's News for Mesoblast" on my trading platform... meaning this could fly under the radar for the average uninformed investor... The hazard of releasing news on a Sunday in the US.
  • P
    Prasanna
    Keeping it to the last moment 🤨
  • a
    andy
    where can I get the latest news on meso ?
  • C
    Christian
    Can someone please remind me what happened with the publication in The NEJM?
  • L
    Left-e
    Here's my take, again, for what it's worth. The company is pursuing a “well-defined process” to resolve a disagreement it has with the FDA over the CRL for rem-L. Substitute the word “re-submission” for “process”. Every meeting with the FDA or one of its sub-agencies and offices is part of the re-submission process. It's a rolling process over time involving mountains of new data and analysis. It's not a finite event. It has taken 2 years with back and forth communications following various data submissions and meetings. When SI says he expects “re-submission by the end of this quarter”, he's talking about the “well-defined process” coming to an end – any other wording subjects him to potential accusations. The end of the well-defined process will be a material event. And the TIMING ultimately depends on the FDA, not SI, which is why he can't say anything stronger than “expects”. Either the FDA is going to agree to give rem-L another full look, as manifested by the issuance of a PDUFA date, or the FDA is going to say, “no matter what you submit, we're not going to review rem-L until you.... run another trial, for example”. The FDA has been known to surprise so a full on-the-spot approval after 2 years of re-evaluation is also possible, but less likely. IMHO Mesoblast is not going to say anything in a PR that is short of a material event involving feedback from the FDA. I could be wrong. We'll see. I own a lot of shares, but the TIMING of the “re-submission” is one issue over which I have ZERO concerns, because I'm convinced the timing of a PR is ultimately controlled by the snail-paced FDA. But if you're feeling a lot of anxiety over the arbitrary date of September 30, as opposed to say October 4, ... if you're getting white knuckles or a sinking feeling, you just might be over-invested. Really. Consider cutting back and “sitting in a coil position” a la Groupie ready to spring faster than a Wahoo thread deletion. Because it could go south if the FDA says no. Even if the FDA accepts the “re-submission” for full review, they could say no again to an approval. I'd worry more about what the FDA is thinking than some arbitrary timing of a data dump by the Company. glta
  • M
    MarketMania
    @GroupInvestor - really?! I bought the majority of my MESO stock below $5 years ago and sold covered calls numerous times to protect my investment. Even when Left-e and others warned me that it was risky. I've always called it the way I've seen it. You claim you don't short stocks. You talk a big game - yet you won't put your money where your mouth is. I'll repeat what I said, you've been right - to date - a lot of nah sayers have been right based on a lot stocks trading near their lows. So your argument that when/if it goes up - I'll claim victory is PATHETIC.

    Please short it!! Have conviction in own knowledge! The knowledge you continue to brag about. If you don't, you're afraid of MESO's potential. If you don't short it - you're agreeing with EVERYONE here that the potential is HUGE and you're SCARED.

    Good luck!
  • a
    anonymity